No

Anti-inflammatory, Locally Applied

Treatment of aphthous ulcers (ie, canker sores); has been investigated in many allergic disorders

B

Due to lack of data, avoid use in pregnancy or lactation, if possible

Hypersensitivity to amlexanox or components

Discontinue therapy if rash or contact mucositis develops

1% to 2%:

Dermatologic: Allergic contact dermatitis

Gastrointestinal: Oral irritation

<1%: Contact mucositis

As a benzopyrano-bipyridine carboxylic acid derivative, amlexanox has anti-inflammatory and antiallergic properties; it inhibits chemical mediatory release of the slow-reacting substance of anaphylaxis (SRS-A) and may have antagonistic effect son interleukin-3

Absorption: Systemic absorption with swallowing of topical application of oral paste

Metabolism: Metabolized to hydroxylated and conjugated product

Half-life: 3.5 hours

Time to peak serum concentration: 2 hours

Elimination: 17% excreted unchanged

Administer (0.5 cm - 1/4 ") directly on ulcers 4 times/day following oral hygiene, after meals, and at bedtime

None reported

None reported

No information available to require special precautions

Discontinue therapy if rash or contact mucositis develops

Apply as soon as possible and continue 4 times/day (after meals and at bedtime); wash hands after use; contact physician if no reduction in pain occurs within 10 days

Paste: 5% (5 g)

Greer RO Jr, Lindenmuth JE, Juarez T, et al, "A Double-Blind Study of Topically Applied 5% Amlexanox in the Treatment of Aphthous Ulcers," J Oral Maxillofac Surg, 1993, 51(3):243-8.